Anorexia NervosaAAMIAMNCT05842343
Food Intake and IgA Microbiota in Anorexia Nervosa
A study testing Stool sample and Food intake evaluation in people with Anorexia Nervosa and Healthy Volunteer, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Anorexia nervosa is characterized by intestinal dysbiosis, related to the feeding behavior impairment presented by these patients. Pathophysiologic hypotheses are involving the trouble of the microbiota-gut-brain axis in the field of mental diseases. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa, Healthy Volunteer
- What is being tested?
- Stool sample and Food intake evaluation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- 13 Oct 2023to 2 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- female subject, adult, affiliated to a social security system, under the care of the eating disorder department of university hospital of st Etienne
- presenting a diagnosis of pure restrictive anorexia nervosa.
- For acute subgroup : BMI between 11 and 17.5 kg/m2, patient with a first episode of restrictive anorexia nervosa or with hyperphagic episodes.
- For the chronic subgroup: BMI between 11 and 17.5 kg/m2, disease evolving for more than 5 years.
- For Healthy volunteer: BMI between 20 and 24 kg/m², stable weight for the last 3 months, no eating disorder or history of eating disorder
Who cannot join
- patient does not understand French.
- laxative treatment in progress or stopped for less than 15 days,
- antibiotic treatment in the two months preceding inclusion,
- pre-pro or symbiotic treatment in progress or in the month preceding inclusion,
- patient with one of the following comorbid disorders: celiac disease, chronic inflammatory bowel disease, lactose intolerance, unstabilized hyperthyroidism, unstabilized diabetes,
- subject under legal protective measures.
Trial locations and contacts
1 site in 1 country.
About this study
Anorexia nervosa is characterized by intestinal dysbiosis, related to the feeding behavior impairment presented by these patients. Pathophysiologic hypotheses are involving the trouble of the microbiota-gut-brain axis in the field of mental diseases.
Read the detailed description
Anorexia nervosa is characterized by intestinal dysbiosis, related to the feeding behavior impairment presented by these patients. Here we aim to characterize the IgA-coated fraction of bacteria from the intestinal microbiota, linked to the regulation of the mucosal immune system and the epithelium physiology. Abnormalities of this microbiota are reported in inflammatory bowel disease and are associated to immune trouble. As food intake plays a key role in shaping microbiota, we aim to correlate data from IgA microbiota to food intake specificity, and to anorexia nervosa phenotypes.
- Conditions
- Anorexia Nervosa, Healthy Volunteer
- Being tested
- Stool sample, Food intake evaluation
- Keywords
- anorexia nervosa, microbiota, gut-brain-axis, immunology (IgA)
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stool sampleOther
Purification by affinity of the IgA coated bacteria from a fecal solution. Genomic analysis of the bacteria for diversity and richness
Food intake evaluationOther
Measure (by survey) of food group intake for : lipids /proteins / fibers / carbohydrates
| Study group | Role | What they receive |
|---|---|---|
| Acute anorexia nervosa | Experimental | patient diagnose for a first episode of pure restrictive anorexia nervosa will be included. They will have stool sample and Food intake evaluation. Receives: Other: Stool sample; Other: Food intake evaluation |
| Chronic anorexia nervosa | Experimental | Patient diagnose for anorexia nervosa at least 5 years ago and still maintaining a significant thinness will be included. They will have stool sample and Food intake evaluation. Receives: Other: Stool sample; Other: Food intake evaluation |
| Healthy control | Placebo comparator | Healthy Patient will be included. They will have stool sample and Food intake evaluation. Receives: Other: Stool sample; Other: Food intake evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total microbiotic profile
abundance and diversity parameters of the IgA microbiota fraction of the intestinal microbiota obtained by 16s rDNA analysis of stool suspension samples from acute anorexia nervosa, chronic anorexia nervosa and control subjects.
Measured: 1 week after inclusion
Secondary outcomes (3)
ELISA assay of fecal immunoglobulins
ELISA determination of immunoglobulin A and immunoglobulin M in the stool of acute anorexia nervosa, chronic anorexia nervosa and control subjects.
Measured: 1 week after inclusion
Microbiotic profile of total intestinal microbiota
Total microbiotic profile (abundance and diversity) of the intestinal microbiota obtained by 16s rDNA analysis of stool suspension samples from acute anorexia nervosa, chronic anorexia nervosa and control subjects.
Measured: 1 week after inclusion
Food intake characteristics
Qualitative and quantitative assessment of dietary intake by a dietary survey of acute anorexia nervosa, chronic anorexia nervosa and control subjects.
Measured: 1 week after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start13 Oct 2023
- Primary completion28 Nov 2023
- Study completion2 Feb 2024
Why it stopped: The coordinating investigator left the sponsor institution and has not been replaced.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement, Laboratory Physiopathologie et biotherapies des infections muqueuses (GIMAP)
- Responsible party
- Sponsor
- Investigators
- Tristan GABRIEL-SEGARD, Md, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05842343
- Sponsor's protocol ID
- 22CH356
- Other IDs
- 2023-A00318-37
- Acronym
- AAMIAM
- Status last verified
- Nov 2025
- First submitted
- 24 Apr 2023
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food Intake and IgA Microbiota in Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT05842343
- Acronym / sponsor ID
- AAMIAM / 22CH356
- Conditions
- Anorexia Nervosa, Healthy Volunteer
- Keywords
- anorexia nervosa, microbiota, gut-brain-axis, immunology (IgA)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The coordinating investigator left the sponsor institution and has not been replaced.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement, Laboratory Physiopathologie et biotherapies des infections muqueuses (GIMAP)
- Study start
- 13 Oct 2023 (actual)
- Primary completion
- 28 Nov 2023 (actual)
- Study completion
- 2 Feb 2024 (actual)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Anorexia nervosa is characterized by intestinal dysbiosis, related to the feeding behavior impairment presented by these patients. Pathophysiologic hypotheses are involving the trouble of the microbiota-gut-brain axis in the field of mental diseases.
Detailed description
Anorexia nervosa is characterized by intestinal dysbiosis, related to the feeding behavior impairment presented by these patients. Here we aim to characterize the IgA-coated fraction of bacteria from the intestinal microbiota, linked to the regulation of the mucosal immune system and the epithelium physiology. Abnormalities of this microbiota are reported in inflammatory bowel disease and are associated to immune trouble. As food intake plays a key role in shaping microbiota, we aim to correlate data from IgA microbiota to food intake specificity, and to anorexia nervosa phenotypes.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acute anorexia nervosa | Experimental | Other: Stool sample, Other: Food intake evaluationpatient diagnose for a first episode of pure restrictive anorexia nervosa will be included. They will have stool sample and Food intake evaluation. |
| Chronic anorexia nervosa | Experimental | Other: Stool sample, Other: Food intake evaluationPatient diagnose for anorexia nervosa at least 5 years ago and still maintaining a significant thinness will be included. They will have stool sample and Food intake evaluation. |
| Healthy control | Placebo comparator | Other: Stool sample, Other: Food intake evaluationHealthy Patient will be included. They will have stool sample and Food intake evaluation. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- female subject, adult, affiliated to a social security system, under the care of the eating disorder department of university hospital of st Etienne
- presenting a diagnosis of pure restrictive anorexia nervosa.
- For acute subgroup : BMI between 11 and 17.5 kg/m2, patient with a first episode of restrictive anorexia nervosa or with hyperphagic episodes.
- For the chronic subgroup: BMI between 11 and 17.5 kg/m2, disease evolving for more than 5 years.
- For Healthy volunteer: BMI between 20 and 24 kg/m², stable weight for the last 3 months, no eating disorder or history of eating disorder
Key exclusion criteria (6 listed)
- patient does not understand French.
- laxative treatment in progress or stopped for less than 15 days,
- antibiotic treatment in the two months preceding inclusion,
- pre-pro or symbiotic treatment in progress or in the month preceding inclusion,
- patient with one of the following comorbid disorders: celiac disease, chronic inflammatory bowel disease, lactose intolerance, unstabilized hyperthyroidism, unstabilized diabetes,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stool samplePurification by affinity of the IgA coated bacteria from a fecal solution. Genomic analysis of the bacteria for diversity and richness | Other | Acute anorexia nervosa, Chronic anorexia nervosa, Healthy control |
| Food intake evaluationMeasure (by survey) of food group intake for : lipids /proteins / fibers / carbohydrates | Other | Acute anorexia nervosa, Chronic anorexia nervosa, Healthy control |
Primary outcome
Total microbiotic profile
Time frame: 1 week after inclusion
abundance and diversity parameters of the IgA microbiota fraction of the intestinal microbiota obtained by 16s rDNA analysis of stool suspension samples from acute anorexia nervosa, chronic anorexia nervosa and control subjects.
3 secondary outcomes
ELISA assay of fecal immunoglobulins
Time frame: 1 week after inclusion
Microbiotic profile of total intestinal microbiota
Time frame: 1 week after inclusion
Food intake characteristics
Time frame: 1 week after inclusion
Results and safety
The study was stopped early (reason given: The coordinating investigator left the sponsor institution and has not been replaced.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tristan GABRIEL-SEGARD, Md principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stool sample and Food intake evaluation in people with Anorexia Nervosa and Healthy Volunteer, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The coordinating investigator left the sponsor institution and has not been replaced.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total microbiotic profile (time frame: 1 week after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.